MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH BIDIRECT

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Tachycardia (2095); Unspecified Nervous System Problem (4426)

Event Date 08/17/2023

Event Type  Injury  

Manufacturer Narrative

E 1.Initial reporter phone : (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial flutter-left ablation procedure that included a thermocool® smart touch® sf bi-directional navigation catheter.The patient experienced neurologic complication (speech difficulties) and tachycardia that required prolonged hospitalization.It was reported that after a few minutes of supraventricular tachycardia ablation, the anesthesia team noticed that the patient presented with speech difficulties.The physician decided to pull out the catheters and sheaths.Sedation was first stopped, and the patient was subjected to neurological test: speech ability, language understanding, pupil dilations and arms/legs movability.The physician suspected a neurological deficit and therefore, the patient was immediately transported to the hospital for further examination.The physician¿s opinion was that no biosense websters products caused the possible neurological deficit.The physician's opinion on the cause of this adverse event was that it was patient condition, not product related.Anesthesia given was deep sedation with propofol.Activated clotting time (act) was controlled several times during the procedure.Max power: 40w.Force visualization features used: graph, dashboard, vector.Parameters for stability used: 3s 3 mm.No additional filter used.Color options used: other.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17742707
• MDR Text Key: 323360271
• Report Number: 2029046-2023-02072
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 6FR CS,F,10 POLE,12 PIN,AUTOID; CARTO3 EXTERNAL REFPATCH 6PACK; PENTARAY NAV ECO 7FR, D, 2-6-2; SMARTABLATE IRR TUBE SET; UNK BRAND SHEATH; UNK_CARTO 3; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Hospitalization